Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
<!-- Product Specification -->
<Bundle xmlns="http://hl7.org/fhir">
<id value="bundle-drug-product-specification-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-specification-pq"/>
</meta>
<type value="collection"/>
<entry>
<fullUrl value="urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265a"/>
<resource>
<PlanDefinition>
<!-- <id value="specificationProtocol"/> -->
<!-- id value="plandefinition-drug-specification-dxpq-ex1"/ -->
<id value="plandefinition-drug-pq-ex3-drug-specification"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: PlanDefinition</b><a name="plandefinition-drug-pq-ex3-drug-specification"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource PlanDefinition "plandefinition-drug-pq-ex3-drug-specification" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a</code></p><p><b>title</b>: SPECIFICATION(S) FOR DRUG PRODUCT</p><p><b>status</b>: active</p><p><b>subject</b>: <a href="#MedicinalProductDefinition_a0694a7a-aafa-4cbe-8135-c788a9a4d3d5">See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)</a></p><p><b>description</b>: Narrative description of specifications</p><blockquote><p><b>action</b></p><p><b>title</b>: Specification(s) for Drug Product</p><p><b>code</b>: Overall set of actions <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><blockquote><p><b>action</b></p><p><b>title</b>: Release</p><p><b>code</b>: Timing Group <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>timing</b>: Code: Release time</p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: End of shelf life</p><p><b>code</b>: Timing Group <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>timing</b>: Code: At end of shelf life</p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote></div>
</text>
<!-- <meta>
<profile value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"/>
</meta> -->
<!-- http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a -->
<url
value="http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a"/>
<title value="SPECIFICATION(S) FOR DRUG PRODUCT"/>
<status value="active"/>
<subjectReference>
<!-- MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1 -->
<reference
value="MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
</subjectReference>
<description value="Narrative description of specifications"/>
<action>
<!-- this is then entire thing -->
<title value="Specification(s) for Drug Product"/>
<code>
<text value="Overall set of actions"/>
</code>
<action>
<title value="Release"/>
<code>
<text value="Timing Group"/>
</code>
<timingTiming>
<code>
<text value="Release time"/>
</code>
</timingTiming>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/Description -->
<definitionCanonical
value="ObservationDefinition/77e7020a-270c-6bed-2e55-28e9e942546c"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/Identification -->
<definitionCanonical
value="ObservationDefinition/0d0ef4cf-242c-1cb1-81c4-c41837ee9a12"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/Assay -->
<definitionCanonical
value="ObservationDefinition/c0f05343-5b98-6073-1a0f-873aaf4f59bc"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/Degradation -->
<definitionCanonical
value="ObservationDefinition/a3d4d23a-800a-684a-6a47-fcfe44e06041"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/Dissolution -->
<definitionCanonical
value="ObservationDefinition/bb11322b-9470-4f13-91b5-c8a5253380eb"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/Uniformity -->
<definitionCanonical
value="ObservationDefinition/e7e2fe59-5433-5cc0-84b1-d5f30032790c"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/Microbiological -->
<definitionCanonical
value="ObservationDefinition/64972eb3-99ee-7eae-2f63-733e5ae84f71"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/Water -->
<definitionCanonical
value="ObservationDefinition/6ce8ab6d-55e2-0412-5fb1-ab33763f30b1"/>
</action>
</action>
<action>
<title value="End of shelf life"/>
<code>
<text value="Timing Group"/>
</code>
<timingTiming>
<code>
<text value="At end of shelf life"/>
</code>
</timingTiming>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/DescriptionEnd -->
<definitionCanonical
value="ObservationDefinition/d24ce3cd-213d-4935-97cf-8e2dd03721ec"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/IdentificationEnd -->
<definitionCanonical
value="ObservationDefinition/f77ba972-5ef8-a178-9a5f-fe7f54da7499"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/AssayEnd -->
<definitionCanonical
value="ObservationDefinition/f4a74fd3-876e-38ce-021f-04e5a8fb6a3f"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/DegradationEnd -->
<definitionCanonical
value="ObservationDefinition/ef72eeb7-211a-3c16-8460-8725ca43584f"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/DissolutionEnd -->
<definitionCanonical
value="ObservationDefinition/6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/UniformityEnd -->
<definitionCanonical
value="ObservationDefinition/43dbc2a3-00c4-6f79-6b11-63768b412aa3"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/MicrobiologicalEnd -->
<definitionCanonical
value="ObservationDefinition/e582e504-36ec-3b50-4043-51bf1147124e"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/WaterEnd -->
<definitionCanonical
value="ObservationDefinition/91391017-774b-5c77-93fa-642534278851"/>
</action>
</action>
</action>
</PlanDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:77e7020a-270c-6bed-2e55-28e9e942546c"/>
<resource>
<ObservationDefinition>
<!-- Description -->
<id value="77e7020a-270c-6bed-2e55-28e9e942546c"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="77e7020a-270c-6bed-2e55-28e9e942546c"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "77e7020a-270c-6bed-2e55-28e9e942546c" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/77e7020a-270c-6bed-2e55-28e9e942546c</code></p><p><b>title</b>: Description</p><p><b>status</b>: active</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>method</b>: Visual inspection <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/77e7020a-270c-6bed-2e55-28e9e942546c -->
<url
value="http://example-server.com/fhir/ObservationDefinition/77e7020a-270c-6bed-2e55-28e9e942546c"/>
<title value="Description"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DESC"/>
<display value="Description"/>
</coding>
<text value="Description"/>
</code>
<method>
<text value="Visual inspection"/>
</method>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString
value="An orange film-coated tablet, debossed with 175 on one side"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:d24ce3cd-213d-4935-97cf-8e2dd03721ec"/>
<resource>
<ObservationDefinition>
<!-- DescriptionEnd -->
<id value="d24ce3cd-213d-4935-97cf-8e2dd03721ec"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="d24ce3cd-213d-4935-97cf-8e2dd03721ec"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "d24ce3cd-213d-4935-97cf-8e2dd03721ec" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/d24ce3cd-213d-4935-97cf-8e2dd03721ec</code></p><p><b>title</b>: Description</p><p><b>status</b>: active</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/d24ce3cd-213d-4935-97cf-8e2dd03721ec -->
<url
value="http://example-server.com/fhir/ObservationDefinition/d24ce3cd-213d-4935-97cf-8e2dd03721ec"/>
<title value="Description"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DESC"/>
<display value="Description"/>
</coding>
<text value="Description"/>
</code>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString value="As for release"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:0d0ef4cf-242c-1cb1-81c4-c41837ee9a12"/>
<resource>
<ObservationDefinition>
<!-- Identification -->
<id value="0d0ef4cf-242c-1cb1-81c4-c41837ee9a12"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="0d0ef4cf-242c-1cb1-81c4-c41837ee9a12"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "0d0ef4cf-242c-1cb1-81c4-c41837ee9a12" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/0d0ef4cf-242c-1cb1-81c4-c41837ee9a12</code></p><p><b>title</b>: Identification</p><p><b>status</b>: active</p><p><b>code</b>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>method</b>: ID by UHPLC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/0d0ef4cf-242c-1cb1-81c4-c41837ee9a12 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/0d0ef4cf-242c-1cb1-81c4-c41837ee9a12"/>
<title value="Identification"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IDT"/>
<display value="Identification"/>
</coding>
<text value="Identification"/>
</code>
<method>
<text value="ID by UHPLC"/>
</method>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString
value="Consistent with the retention time and UV spectrum of the reference standard"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:f77ba972-5ef8-a178-9a5f-fe7f54da7499"/>
<resource>
<ObservationDefinition>
<!-- IdentificationEnd -->
<id value="f77ba972-5ef8-a178-9a5f-fe7f54da7499"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="f77ba972-5ef8-a178-9a5f-fe7f54da7499"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "f77ba972-5ef8-a178-9a5f-fe7f54da7499" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/f77ba972-5ef8-a178-9a5f-fe7f54da7499</code></p><p><b>title</b>: Identification</p><p><b>status</b>: active</p><p><b>code</b>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/f77ba972-5ef8-a178-9a5f-fe7f54da7499 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/f77ba972-5ef8-a178-9a5f-fe7f54da7499"/>
<title value="Identification"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IDT"/>
<display value="Identification"/>
</coding>
<text value="Identification"/>
</code>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString value="As for release"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:c0f05343-5b98-6073-1a0f-873aaf4f59bc"/>
<resource>
<ObservationDefinition>
<!-- Assay -->
<id value="c0f05343-5b98-6073-1a0f-873aaf4f59bc"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="c0f05343-5b98-6073-1a0f-873aaf4f59bc"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "c0f05343-5b98-6073-1a0f-873aaf4f59bc" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/c0f05343-5b98-6073-1a0f-873aaf4f59bc</code></p><p><b>title</b>: Assay</p><p><b>status</b>: active</p><p><b>code</b>: Assay <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>method</b>: Assay by UHPLC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/c0f05343-5b98-6073-1a0f-873aaf4f59bc -->
<url
value="http://example-server.com/fhir/ObservationDefinition/c0f05343-5b98-6073-1a0f-873aaf4f59bc"/>
<title value="Assay"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="ASSAY"/>
<display value="Assay"/>
</coding>
<text value="Assay"/>
</code>
<method>
<text value="Assay by UHPLC"/>
</method>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString value="95% to 105% of label claim"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:f4a74fd3-876e-38ce-021f-04e5a8fb6a3f"/>
<resource>
<ObservationDefinition>
<!-- AssayEnd -->
<id value="f4a74fd3-876e-38ce-021f-04e5a8fb6a3f"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="f4a74fd3-876e-38ce-021f-04e5a8fb6a3f"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "f4a74fd3-876e-38ce-021f-04e5a8fb6a3f" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/f4a74fd3-876e-38ce-021f-04e5a8fb6a3f</code></p><p><b>title</b>: Assay</p><p><b>status</b>: active</p><p><b>code</b>: Assay <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/f4a74fd3-876e-38ce-021f-04e5a8fb6a3f -->
<url
value="http://example-server.com/fhir/ObservationDefinition/f4a74fd3-876e-38ce-021f-04e5a8fb6a3f"/>
<title value="Assay"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="ASSAY"/>
<display value="Assay"/>
</coding>
<text value="Assay"/>
</code>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString value="As for release"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:a3d4d23a-800a-684a-6a47-fcfe44e06041"/>
<resource>
<ObservationDefinition>
<!-- Degradation -->
<id value="a3d4d23a-800a-684a-6a47-fcfe44e06041"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="a3d4d23a-800a-684a-6a47-fcfe44e06041"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "a3d4d23a-800a-684a-6a47-fcfe44e06041" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/a3d4d23a-800a-684a-6a47-fcfe44e06041</code></p><p><b>title</b>: Degradation Products</p><p><b>status</b>: active</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>method</b>: Degradation products by UHPLC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 1 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.2</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.3</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 3 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.3</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Individual unspecified degradation products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.2</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Total degradation products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-1.4</p></blockquote><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/a3d4d23a-800a-684a-6a47-fcfe44e06041 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/a3d4d23a-800a-684a-6a47-fcfe44e06041"/>
<title value="Degradation Products"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
</code>
<method>
<text value="Degradation products by UHPLC"/>
</method>
<qualifiedValue>
<appliesTo>
<!-- could be a code -->
<text value="Impurity 1"/>
</appliesTo>
<range>
<high>
<value value="0.2"/>
<unit value="% w/w"/>
</high>
</range>
</qualifiedValue>
<qualifiedValue>
<appliesTo>
<text value="Impurity 2"/>
</appliesTo>
<range>
<high>
<value value="0.3"/>
<unit value="% w/w"/>
</high>
</range>
</qualifiedValue>
<qualifiedValue>
<appliesTo>
<text value="Impurity 3"/>
</appliesTo>
<range>
<high>
<value value="0.3"/>
<unit value="% w/w"/>
</high>
</range>
</qualifiedValue>
<qualifiedValue>
<appliesTo>
<text value="Individual unspecified degradation products"/>
</appliesTo>
<range>
<high>
<value value="0.2"/>
<unit value="% w/w"/>
</high>
</range>
</qualifiedValue>
<qualifiedValue>
<appliesTo>
<text value="Total degradation products"/>
</appliesTo>
<range>
<high>
<value value="1.4"/>
<unit value="% w/w"/>
</high>
</range>
</qualifiedValue>
<component>
<!-- are expected to have a component that says what impurity this one is -->
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
</component>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:ef72eeb7-211a-3c16-8460-8725ca43584f"/>
<resource>
<ObservationDefinition>
<!-- DegradationEnd -->
<id value="ef72eeb7-211a-3c16-8460-8725ca43584f"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="ef72eeb7-211a-3c16-8460-8725ca43584f"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "ef72eeb7-211a-3c16-8460-8725ca43584f" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/ef72eeb7-211a-3c16-8460-8725ca43584f</code></p><p><b>title</b>: Degradation Products</p><p><b>status</b>: active</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 1 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.8</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.4</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 3 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.4</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Individual unspecified degradation products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-2.3</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Total degradation products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-2.3</p></blockquote><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/ef72eeb7-211a-3c16-8460-8725ca43584f -->
<url
value="http://example-server.com/fhir/ObservationDefinition/ef72eeb7-211a-3c16-8460-8725ca43584f"/>
<title value="Degradation Products"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
</code>
<qualifiedValue>
<appliesTo>
<!-- could be a code -->
<text value="Impurity 1"/>
</appliesTo>
<range>
<high>
<value value="0.8"/>
<unit value="% w/w"/>
</high>
</range>
</qualifiedValue>
<qualifiedValue>
<appliesTo>
<text value="Impurity 2"/>
</appliesTo>
<range>
<high>
<value value="0.4"/>
<unit value="% w/w"/>
</high>
</range>
</qualifiedValue>
<qualifiedValue>
<appliesTo>
<text value="Impurity 3"/>
</appliesTo>
<range>
<high>
<value value="0.4"/>
<unit value="% w/w"/>
</high>
</range>
</qualifiedValue>
<qualifiedValue>
<appliesTo>
<text value="Individual unspecified degradation products"/>
</appliesTo>
<range>
<high>
<value value="2.3"/>
<unit value="% w/w"/>
</high>
</range>
</qualifiedValue>
<qualifiedValue>
<appliesTo>
<text value="Total degradation products"/>
</appliesTo>
<range>
<high>
<value value="2.3"/>
<unit value="% w/w"/>
</high>
</range>
</qualifiedValue>
<component>
<!-- are expected to have a component that says what impurity this one is -->
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
</component>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:bb11322b-9470-4f13-91b5-c8a5253380eb"/>
<resource>
<ObservationDefinition>
<!-- Dissolution -->
<id value="bb11322b-9470-4f13-91b5-c8a5253380eb"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="bb11322b-9470-4f13-91b5-c8a5253380eb"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "bb11322b-9470-4f13-91b5-c8a5253380eb" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/bb11322b-9470-4f13-91b5-c8a5253380eb</code></p><p><b>title</b>: Dissolution</p><p><b>status</b>: active</p><p><b>code</b>: Dissolution <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Dissolution)</span></p><p><b>method</b>: Apparatus 2 (paddles), UV measurement <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/bb11322b-9470-4f13-91b5-c8a5253380eb -->
<url
value="http://example-server.com/fhir/ObservationDefinition/bb11322b-9470-4f13-91b5-c8a5253380eb"/>
<title value="Dissolution"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Dissolution"/>
<display value="Dissolution"/>
</coding>
<text value="Dissolution"/>
</code>
<method>
<text value="Apparatus 2 (paddles), UV measurement"/>
</method>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString
value="Shall comply with the requirements of the harmonised USP/JP/Ph Eur Q=80% at 30 minutes"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea"/>
<resource>
<ObservationDefinition>
<!-- DissolutionEnd -->
<id value="6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea</code></p><p><b>title</b>: Dissolution</p><p><b>status</b>: active</p><p><b>code</b>: Dissolution <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Dissolution)</span></p><p><b>method</b>: Apparatus 2 (paddles), UV measurement <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea -->
<url
value="http://example-server.com/fhir/ObservationDefinition/6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea"/>
<title value="Dissolution"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Dissolution"/>
<display value="Dissolution"/>
</coding>
<text value="Dissolution"/>
</code>
<method>
<text value="Apparatus 2 (paddles), UV measurement"/>
</method>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString value="As for release"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:6ce8ab6d-55e2-0412-5fb1-ab33763f30b1"/>
<resource>
<ObservationDefinition>
<!-- Water -->
<id value="6ce8ab6d-55e2-0412-5fb1-ab33763f30b1"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="6ce8ab6d-55e2-0412-5fb1-ab33763f30b1"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "6ce8ab6d-55e2-0412-5fb1-ab33763f30b1" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/6ce8ab6d-55e2-0412-5fb1-ab33763f30b1</code></p><p><b>title</b>: Water Content</p><p><b>status</b>: active</p><p><b>code</b>: Water Content <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>method</b>: USP <921> <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Range</b></td></tr><tr><td style="display: none">*</td><td>?-1.0</td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/6ce8ab6d-55e2-0412-5fb1-ab33763f30b1 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/6ce8ab6d-55e2-0412-5fb1-ab33763f30b1"/>
<title value="Water Content"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="WaterContent"/>
<display value="Water Content"/>
</coding>
<text value="Water Content"/>
</code>
<method>
<text value="USP <921>"/>
</method>
<qualifiedValue>
<range>
<high>
<value value="1.0"/>
<unit value="% w/w"/>
</high>
</range>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:91391017-774b-5c77-93fa-642534278851"/>
<resource>
<ObservationDefinition>
<!-- WaterEnd -->
<id value="91391017-774b-5c77-93fa-642534278851"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="91391017-774b-5c77-93fa-642534278851"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "91391017-774b-5c77-93fa-642534278851" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/91391017-774b-5c77-93fa-642534278851</code></p><p><b>title</b>: Water Content</p><p><b>status</b>: active</p><p><b>code</b>: Water Content <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>method</b>: USP <921> <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Range</b></td></tr><tr><td style="display: none">*</td><td>?-2.0</td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/91391017-774b-5c77-93fa-642534278851 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/91391017-774b-5c77-93fa-642534278851"/>
<title value="Water Content"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="WaterContent"/>
<display value="Water Content"/>
</coding>
<text value="Water Content"/>
</code>
<method>
<text value="USP <921>"/>
</method>
<qualifiedValue>
<range>
<high>
<value value="2.0"/>
<unit value="% w/w"/>
</high>
</range>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:64972eb3-99ee-7eae-2f63-733e5ae84f71"/>
<resource>
<ObservationDefinition>
<!-- Microbiological -->
<id value="64972eb3-99ee-7eae-2f63-733e5ae84f71"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="64972eb3-99ee-7eae-2f63-733e5ae84f71"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "64972eb3-99ee-7eae-2f63-733e5ae84f71" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/64972eb3-99ee-7eae-2f63-733e5ae84f71</code></p><p><b>title</b>: Microbiological</p><p><b>status</b>: active</p><p><b>code</b>: Microbiological Quality <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>method</b>: Ph Eur <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/64972eb3-99ee-7eae-2f63-733e5ae84f71 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/64972eb3-99ee-7eae-2f63-733e5ae84f71"/>
<title value="Microbiological"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Microbiological Quality"/>
<display value="Microbiological Quality"/>
</coding>
<text value="Microbiological Quality"/>
</code>
<method>
<text value="Ph Eur"/>
</method>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString
value="Shall comply with the requirements of the Ph Eur"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:e582e504-36ec-3b50-4043-51bf1147124e"/>
<resource>
<ObservationDefinition>
<!-- MicrobiologicalEnd -->
<id value="e582e504-36ec-3b50-4043-51bf1147124e"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="e582e504-36ec-3b50-4043-51bf1147124e"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "e582e504-36ec-3b50-4043-51bf1147124e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/e582e504-36ec-3b50-4043-51bf1147124e</code></p><p><b>title</b>: Microbiological</p><p><b>status</b>: active</p><p><b>code</b>: Microbiological Quality <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>method</b>: Ph Eur <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/e582e504-36ec-3b50-4043-51bf1147124e -->
<url
value="http://example-server.com/fhir/ObservationDefinition/e582e504-36ec-3b50-4043-51bf1147124e"/>
<title value="Microbiological"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Microbiological Quality"/>
<display value="Microbiological Quality"/>
</coding>
<text value="Microbiological Quality"/>
</code>
<method>
<text value="Ph Eur"/>
</method>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString value="As for release"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:e7e2fe59-5433-5cc0-84b1-d5f30032790c"/>
<resource>
<ObservationDefinition>
<!-- Uniformity -->
<id value="e7e2fe59-5433-5cc0-84b1-d5f30032790c"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="e7e2fe59-5433-5cc0-84b1-d5f30032790c"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "e7e2fe59-5433-5cc0-84b1-d5f30032790c" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/e7e2fe59-5433-5cc0-84b1-d5f30032790c</code></p><p><b>title</b>: Uniformity of dosage</p><p><b>status</b>: active</p><p><b>code</b>: uniformity of dosage units (by weight) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#uniformity-dosage)</span></p><p><b>method</b>: Weight variation <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/e7e2fe59-5433-5cc0-84b1-d5f30032790c -->
<url
value="http://example-server.com/fhir/ObservationDefinition/e7e2fe59-5433-5cc0-84b1-d5f30032790c"/>
<title value="Uniformity of dosage"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="uniformity-dosage"/>
<display value="uniformity of dosage units (by weight)"/>
</coding>
<text value="uniformity of dosage units (by weight)"/>
</code>
<method>
<text value="Weight variation"/>
</method>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString
value="Shall comply with the requirements of the harmonised USP/JP/Ph Eur"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:43dbc2a3-00c4-6f79-6b11-63768b412aa3"/>
<resource>
<ObservationDefinition>
<!-- UniformityEnd -->
<id value="43dbc2a3-00c4-6f79-6b11-63768b412aa3"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="43dbc2a3-00c4-6f79-6b11-63768b412aa3"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "43dbc2a3-00c4-6f79-6b11-63768b412aa3" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/43dbc2a3-00c4-6f79-6b11-63768b412aa3</code></p><p><b>title</b>: Uniformity of dosage</p><p><b>status</b>: active</p><p><b>code</b>: uniformity of dosage units (by weight) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#uniformity-dosage)</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/43dbc2a3-00c4-6f79-6b11-63768b412aa3 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/43dbc2a3-00c4-6f79-6b11-63768b412aa3"/>
<title value="Uniformity of dosage"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="uniformity-dosage"/>
<display value="uniformity of dosage units (by weight)"/>
</coding>
<text value="uniformity of dosage units (by weight)"/>
</code>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString value="As for release"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<!-- MedicinalProductDefinition - the main resource in any product scenario -->
<entry>
<fullUrl value="urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
<!-- Section 1.1 - DP Identification -->
<resource>
<MedicinalProductDefinition>
<!-- medicinalproductdefinition-drug-product-pq-ex1 -->
<id value="a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: MedicinalProductDefinition</b><a name="a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5" </p></div><p><b>description</b>: Textual description of the product</p><p><b>combinedPharmaceuticalDoseForm</b>: Gastro-resistant tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (standardterms.edqm.eu#10225000)</span></p><p><b>route</b>: Oral use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (standardterms.edqm.eu#20053000)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Stelbat Tablets, 20mg</p><p><b>type</b>: Proprietary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-productNameType-local-pq.html">CodeSystem - Product Name Type</a>#Proprietary)</span></p><h3>Parts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Part</b></td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>20mg</td><td>Strength part <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-medicinal-product-name-part-type.html">Product Name Part Type</a>#StrengthPart)</span></td></tr></table></blockquote></div>
</text>
<description value="Textual description of the product"/>
<combinedPharmaceuticalDoseForm>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="10225000"/>
<display value="Gastro-resistant tablet"/>
</coding>
</combinedPharmaceuticalDoseForm>
<route>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="20053000"/>
<display value="Oral use"/>
</coding>
</route>
<name>
<productName value="Stelbat Tablets, 20mg"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-local-pq"/>
<code value="Proprietary"/>
<display value="Proprietary"/>
</coding>
</type>
<part>
<part value="20mg"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/medicinal-product-name-part-type"/>
<code value="StrengthPart"/>
<display value="Strength part"/>
</coding>
</type>
</part>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d6"/>
<resource>
<Ingredient>
<!-- productIngredient -->
<id value="a0694a7a-aafa-4cbe-8135-c788a9a4d3d6"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Ingredient</b><a name="a0694a7a-aafa-4cbe-8135-c788a9a4d3d6"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Ingredient "a0694a7a-aafa-4cbe-8135-c788a9a4d3d6" </p></div><p><b>status</b>: active</p><p><b>for</b>: <a href="#MedicinalProductDefinition_a0694a7a-aafa-4cbe-8135-c788a9a4d3d5">See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)</a></p><p><b>role</b>: Active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-ingredient-role.html">Ingredient Role</a>#100000072072)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="#SubstanceDefinition_c458791f-7cb8-428e-83f7-8a205f821152">See above (SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152)</a></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>
<!-- MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1 -->
<reference
value="MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
</for>
<role>
<coding>
<system value="http://hl7.org/fhir/ingredient-role"/>
<code value="100000072072"/>
<display value="Active"/>
</coding>
</role>
<substance>
<code>
<reference>
<!-- SubstanceDefinition/substance1 -->
<reference
value="SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152"/>
</reference>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:c458791f-7cb8-428e-83f7-8a205f821152"/>
<resource>
<SubstanceDefinition>
<!-- substance1 -->
<id value="c458791f-7cb8-428e-83f7-8a205f821152"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SubstanceDefinition</b><a name="c458791f-7cb8-428e-83f7-8a205f821152"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821152" </p></div><p><b>manufacturer</b>: <a href="#Organization_9fe98cfa-9245-8313-0fc5-d15e613b5d6d">See above (Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d)</a></p><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td></tr><tr><td style="display: none">*</td><td>Stelbatolol</td></tr></table></div>
</text>
<manufacturer>
<!-- Organization/substance-manufacturer -->
<reference
value="Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d"/>
</manufacturer>
<name>
<name value="Stelbatolol"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:9fe98cfa-9245-8313-0fc5-d15e613b5d6d"/>
<resource>
<Organization>
<!-- substance-manufacturer -->
<id value="9fe98cfa-9245-8313-0fc5-d15e613b5d6d"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Organization</b><a name="9fe98cfa-9245-8313-0fc5-d15e613b5d6d"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Organization "9fe98cfa-9245-8313-0fc5-d15e613b5d6d" </p></div><p><b>identifier</b>: id: 3003040516</p><p><b>name</b>: AAA Molybdenum Products, Inc.</p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Address</b></td></tr><tr><td style="display: none">*</td><td>7233 W 116th Pl Ste C Broomfield Colorado 80020 USA </td></tr></table></div>
</text>
<identifier>
<!-- FDA establishment identifier -->
<system value="urn:oid:2.16.840.1.113883.4.82"/>
<value value="3003040516"/>
</identifier>
<name value="AAA Molybdenum Products, Inc."/>
<contact>
<address>
<line value="7233 W 116th Pl"/>
<line value="Ste C"/>
<city value="Broomfield"/>
<state value="Colorado"/>
<postalCode value="80020"/>
<country value="USA"/>
</address>
</contact>
</Organization>
</resource>
</entry>
</Bundle>
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-18
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